(223 days)
No
The summary describes an immunofluorescence assay kit that uses labeled antibodies to detect pathogens. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is an in vitro diagnostic test used to detect pathogens, not to treat a disease or condition.
Yes
The device is intended for the detection of specific pathogens (Cryptosporidium oocysts and Giardia cysts) in fecal specimens from individuals suspected of having intestinal disease, which is a diagnostic purpose. The description also explicitly mentions its use for "in vitro diagnostic use."
No
The device description clearly outlines a kit containing physical reagents (antibody reagent, mouse ascites fluid) for an in vitro diagnostic test, indicating it is a hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used to detect pathogens in fecal specimens from persons suspected of having intestinal disease. This is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The description details a kit with reagents and antibodies designed to detect specific substances (Cryptosporidium oocysts and Giardia cysts) in a biological sample (fecal specimens). This is characteristic of an IVD.
- Predicate Device: The predicate device mentioned, the Giardia-Cel IF Test (K912152), is explicitly stated as having been cleared for in vitro diagnostic use. This further supports the classification of the current device as an IVD, as it is being compared to a known IVD.
- Performance Studies: The performance studies describe comparisons with other diagnostic tests for detecting these pathogens in fecal specimens, which is typical for the evaluation of an IVD.
N/A
Intended Use / Indications for Use
The TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens.
Product codes
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Device Description
The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of a mixture of FITC-labeled anti-Cryptosporidium monoclonal antibody and FITC-labeled anti-Giardia monoclonal antibody. These antibodies function as the detecting antibodies. The monoclonal antibodies are prepared from mouse ascites fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The TechLab Crypto/Giardia-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of these organisms in fecal specimens. In addition, the TechLab test was compared in one of the studies with the Giardia-Cel IF Test, which has been approved for in vitro diagnostic use, and with the Crypto-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto/Giardia-Cel IF Test exhibits a correlation of 100% when compared with these tests.
Key Metrics
correlation of 100%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
- Name of Manufacturer
TechLab, Inc. Corporate Research Center 1861 Pratt Drive Blacksburg, VA 24060
AUG - 5 1996
- Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
- Trade Name
Crypto/Giardia-Cel IF Test
- Common Name
Cryptosporidium and Giardia Immunofluorescent Test
- Class of Device
This device is classified in Class I.
- Performance Standards
No performance standards have been developed for this device under 514 of the Food, Drug, and Cosmetic Act.
7. Safety and Effectiveness
The TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens. The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of a mixture of FITC-labeled anti-Cryptosporidium monoclonal antibody and FITC-labeled anti-Giardia monoclonal antibody. These antibodies function as the detecting antibodies. The monoclonal antibodies are prepared from mouse ascites fluid. The antibodies against Giardia are the same as those used in the Giardia-Cel IF Test (K912152), which has been cleared for in vitro diagnostic use.
1
The Crypto/Giardia-Cel IF Test is to be used in an immunofluorescent assay and is substantially equivalent to an approved immunofluorescent test that also is specific for Cryptosporidium and Giardia. Both of these tests serve as diagnostic aids for cryptosporidiosis and giardiasis by detecting the organism or its antigens.
The TechLab Crypto/Giardia-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of these organisms in fecal specimens. In addition, the TechLab test was compared in one of the studies with the Giardia-Cel IF Test, which has been approved for in vitro diagnostic use, and with the Crypto-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto/Giardia-Cel IF Test exhibits a correlation of 100% when compared with these tests. These results show that the TechLab Crypto/Giardia-Cel IF Test is useful for the detection of these pathogens in fecal specimens.